15 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LEH·October 12, 2005
(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·March 23, 2022
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 3, 30.0 mm; Ref 96-0537.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
CryoValve, Pulmonary Valve and Conduit
FDA Recall
Terminated
·Cryolife Inc·Product code MIE·January 12, 2005
T2 Recon Nail System.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code HSB·August 12, 2005
Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMI·May 5, 2005
Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DWF·September 12, 2005
Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
FDA Recall
Terminated
·Cordis Corporation·Product code NIQ·January 12, 2005
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
FDA Recall
Terminated
·Siemens Hearing Instruments, Inc·Product code LEZ·July 1, 2005
Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.
FDA Recall
Terminated
·Advanced Bionics Corporation·Product code MCM·July 27, 2004
Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.
FDA Recall
Terminated
·Radiometer America Inc·Product code JQP·March 2, 2005
AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA.
FDA Recall
Terminated
·Possis Medical, Inc·Product code DXE·December 12, 2005
INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=Russian
FDA Recall
Terminated
·Event Medical·Product code CBK·August 12, 2005
product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Manufactured by Pascal Company, Inc. 2929 N.E. Northup Way P.O. Box 1478 Bellevue, WA 98009-1478 USA***''
FDA Recall
Terminated
·Pascal Co Inc·Product code MED·August 9, 2005
D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·January 12, 2005